Difference between revisions of "Study attributes"

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(Created page with "For studies it is useful to provide a basic categorisation of their current recruiting status, to give an idea of where the study is within the normal life cycle. This data is...")
 
 
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For studies it is useful to provide a basic categorisation of their current recruiting status, to give an idea of where the study is within the normal life cycle. This data is often available from trial registry entries.  
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<p style="color:blue; text-align:right"><small>'''''Last updated: 19/04/2022'''''</small></p>
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The study attributes below are all designed to be used in categorised form.  
  
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The options in the NDR system are taken from the largest such registry, ClinicalTrials.gov, (from its overall_status field, which appears to be a combination of the overall recruitment data point and the availability of the relevant data). They are listed below:
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===Study Types===
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This provides a very broad overall classification of clinical studies according to their type. The classification in the MDR system is taken from ClinicalTrials.gov:
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{| class="wikitable" style="width: 95%;"
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|-
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! style="width: 3%; text-align:left;" | id !! style="width: 20%; text-align:left;" | name !! description !! style="width: 15%;" | use_in_data_entry !! style="width: 15%;" | source
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|- style="vertical-align:top;"
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| 11 || Interventional|| style="padding-bottom:10px;" | A clinical trial.|| style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 12 || Observational|| style="padding-bottom:10px;" | Any form of non-interventional research.|| style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 13 || Observational patient registry|| style="padding-bottom:10px;" | Collecting data for a designated registry. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 14 || Expanded access|| style="padding-bottom:10px;" | Off label usage of a new product for individuals. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 15 || Funded programme || style="padding-bottom:10px;" | With a single or linked series of grants. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 16 || Other || style="padding-bottom:10px;" | Source data category does not correspond to any listed above, or is explicitly ‘Other’. || style="text-align:center;" | true || style="text-align:center;" | ISRCTN
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|- style="vertical-align:top;"
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| 0 || Not yet known || style="padding-bottom:10px;" | Dummy value supplied by default on entity creation. || style="text-align:center;" | false|| style="text-align:center;" | ClinicalTrials.gov
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|}
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===Study Statuses===
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This provides a categorisation of a study's current status, to give an idea of where the study is within the normal life cycle. This data is often available from trial registry entries. The options in the MDR system are taken from the largest registry, ClinicalTrials.gov, (from its overall_status field). They are listed below:
  
 
{| class="wikitable" style="width: 95%;"
 
{| class="wikitable" style="width: 95%;"
 
|-
 
|-
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! style="width: 3%; text-align:left;" | id !! style="width: 20%; text-align:left;" | name !! description !! style="width: 15%;" | source
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! style="width: 3%; text-align:left;" | id !! style="width: 20%; text-align:left;" | name !! description !! style="width: 15%;" | use_in_data_entry !! style="width: 15%;" | source
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 11 || Withdrawn|| style="padding-bottom:10px;" | Study halted prematurely, prior to enrolment of first participant. || style="text-align:center;" | ClinicalTrials.gov
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| 11 || Withdrawn || style="padding-bottom:10px;" | Study halted prematurely, prior to enrolment of first participant. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 12 || Available|| style="padding-bottom:10px;" | Recruitment status available on request but no details provided. || style="text-align:center;" | ClinicalTrials.gov
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| 12 || Available|| style="padding-bottom:10px;" | Recruitment status available on request but no details provided. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 13 || Withheld|| style="padding-bottom:10px;" | Recruitment status not provided. || style="text-align:center;" | ClinicalTrials.gov
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| 13 || Withheld|| style="padding-bottom:10px;" | Recruitment status not provided. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 14 || Recruiting|| style="padding-bottom:10px;" | Participants are currently being recruited, whether or not any participants have yet been enrolled. || style="text-align:center;" | ClinicalTrials.gov
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| 14 || Recruiting|| style="padding-bottom:10px;" | Participants are currently being recruited, whether or not any participants have yet been enrolled. || style="text-align:center;" | true  || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 15 || Active, not recruiting|| style="padding-bottom:10px;" | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. || style="text-align:center;" | ClinicalTrials.gov
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| 15 || Active, not recruiting|| style="padding-bottom:10px;" | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 16 || Not yet recruiting|| style="padding-bottom:10px;" | Participants are not yet being recruited. || style="text-align:center;" | ClinicalTrials.gov
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| 16 || Not yet recruiting|| style="padding-bottom:10px;" | Participants are not yet being recruited. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 17 || No longer available|| style="padding-bottom:10px;" | Recruitment status no longer available. || style="text-align:center;" | ClinicalTrials.gov
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| 17 || No longer available|| style="padding-bottom:10px;" | Recruitment status no longer available. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 18 || Suspended|| style="padding-bottom:10px;" | Study halted prematurely but potentially will resume. || style="text-align:center;" | ClinicalTrials.gov
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| 18 || Suspended|| style="padding-bottom:10px;" | Study halted prematurely but potentially will resume. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 19 || Enrolling by invitation|| style="padding-bottom:10px;" | Participants are being (or will be) selected from a predetermined population. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 20 || Approved for marketing || style="padding-bottom:10px;" | The study has concluded and the medical agent that was the focus of the study has been approved for marketing (in the US). || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 21 || Completed|| style="padding-bottom:10px;" | The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 22 || Terminated|| style="padding-bottom:10px;" | Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
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|- style="vertical-align:top;"
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| 24 || Other || style="padding-bottom:10px;" | Status given as "other" in source data. || style="text-align:center;" | true || style="text-align:center;" | WHO
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|- style="vertical-align:top;"
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| 25 || Ongoing || style="padding-bottom:10px;" | Trial is ongoing but recruitment status is unclear.|| style="text-align:center;" | false || style="text-align:center;" | EU CTR
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|- style="vertical-align:top;"
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| 0 || Unknown status|| style="padding-bottom:10px;" | Status information not provided. || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
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|}
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===Gender Eligibility Types===
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Studies may be open only to female participants, or only male, or both. This categorisation reflects that.
 +
{| class="wikitable" style="width: 95%;"
 +
|-
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! style="width: 3%; text-align:left;" | id !! style="width: 20%; text-align:left;" | name !! description !! style="width: 15%;" | use_in_data_entry !! style="width: 15%;" | source
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 19 || Enrolling by invitation|| style="padding-bottom:10px;" | Participants are being (or will be) selected from a predetermined population. || style="text-align:center;" | ClinicalTrials.gov
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| 900 || All ||  || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 20 || Approved for marketing || style="padding-bottom:10px;" | The study has concluded and the medical agent that was the focus of the study has been approved for marketing (in the US). || style="text-align:center;" | ClinicalTrials.gov
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| 905 || Female || || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 21 || Completed|| style="padding-bottom:10px;" | The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). || style="text-align:center;" | ClinicalTrials.gov
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| 910 || Male ||  || style="text-align:center;" | true || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 22 || Terminated|| style="padding-bottom:10px;" | Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.|| style="text-align:center;" | ClinicalTrials.gov
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| 915 || Not provided ||  || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
  
 
|- style="vertical-align:top;"
 
|- style="vertical-align:top;"
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| 0 || Unknown status|| style="padding-bottom:10px;" | Status information not provided. || style="text-align:center;" | ClinicalTrials.gov
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| 0 || Unknown status ||  || style="text-align:center;" | false || style="text-align:center;" | ClinicalTrials.gov
 
|}
 
|}

Latest revision as of 14:50, 10 May 2022

Last updated: 19/04/2022

The study attributes below are all designed to be used in categorised form.

Study Types

This provides a very broad overall classification of clinical studies according to their type. The classification in the MDR system is taken from ClinicalTrials.gov:

id name description use_in_data_entry source
11 Interventional A clinical trial. true ClinicalTrials.gov
12 Observational Any form of non-interventional research. true ClinicalTrials.gov
13 Observational patient registry Collecting data for a designated registry. true ClinicalTrials.gov
14 Expanded access Off label usage of a new product for individuals. true ClinicalTrials.gov
15 Funded programme With a single or linked series of grants. false ClinicalTrials.gov
16 Other Source data category does not correspond to any listed above, or is explicitly ‘Other’. true ISRCTN
0 Not yet known Dummy value supplied by default on entity creation. false ClinicalTrials.gov

Study Statuses

This provides a categorisation of a study's current status, to give an idea of where the study is within the normal life cycle. This data is often available from trial registry entries. The options in the MDR system are taken from the largest registry, ClinicalTrials.gov, (from its overall_status field). They are listed below:

id name description use_in_data_entry source
11 Withdrawn Study halted prematurely, prior to enrolment of first participant. false ClinicalTrials.gov
12 Available Recruitment status available on request but no details provided. false ClinicalTrials.gov
13 Withheld Recruitment status not provided. false ClinicalTrials.gov
14 Recruiting Participants are currently being recruited, whether or not any participants have yet been enrolled. true ClinicalTrials.gov
15 Active, not recruiting Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. true ClinicalTrials.gov
16 Not yet recruiting Participants are not yet being recruited. true ClinicalTrials.gov
17 No longer available Recruitment status no longer available. false ClinicalTrials.gov
18 Suspended Study halted prematurely but potentially will resume. true ClinicalTrials.gov
19 Enrolling by invitation Participants are being (or will be) selected from a predetermined population. false ClinicalTrials.gov
20 Approved for marketing The study has concluded and the medical agent that was the focus of the study has been approved for marketing (in the US). false ClinicalTrials.gov
21 Completed The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). true ClinicalTrials.gov
22 Terminated Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. true ClinicalTrials.gov
24 Other Status given as "other" in source data. true WHO
25 Ongoing Trial is ongoing but recruitment status is unclear. false EU CTR
0 Unknown status Status information not provided. false ClinicalTrials.gov

Gender Eligibility Types

Studies may be open only to female participants, or only male, or both. This categorisation reflects that.

id name description use_in_data_entry source
900 All true ClinicalTrials.gov
905 Female true ClinicalTrials.gov
910 Male true ClinicalTrials.gov
915 Not provided false ClinicalTrials.gov
0 Unknown status false ClinicalTrials.gov
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